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Radformation · 1 month ago

Quality & Regulatory Operations Lead

United States

Full-time

Remote

Senior Level

$140K/yr - $170K/yr

5+ years exp

Radformation is a company focused on creating solutions that detect medical errors and save clinical time for clinicians in radiation therapy. The Quality & Regulatory Operations Lead will supervise the QARA function, ensuring alignment and execution of quality and regulatory deliverables while coordinating with cross-functional partners and maintaining audit-ready documentation.

Health CareHospitalMedical

Growth Opportunities

Responsibilities

Organize and manage timely completion of QARA tasks, including CAPAs and DHF deliverables

Coordinate due dates, dependencies, and status updates to align QARA work with project schedules

Maintain teamwide deliverable trackers with owners, due dates, and dependencies

Partner with deliverable owners to keep status current and identify risks early

Interface with project leaders, RA, and Quality teams to clarify ownership and escalate risks

Ensure QARA deliverables related to design control release timing are tracked by phase

Coordinate the transition to new DHF/DDS templates during QMSR implementation

Utilize eQMS and ALM systems to ensure deliverables are properly stored and audit-ready

Analyze performance data, tools, and templates to identify operational improvements

Assist with international regulatory submissions and global conformity assessment needs

Coordinate the company-wide CAPA system

Lead CAPA investigations, corrections, corrective actions, preventive actions, and effectiveness checks

Host CAPA CRB meetings and present CAPA content during internal and external audits

Conduct CAPA training as needed

Perform other QARA-related duties as assigned (e.g., validation of QARA applications)

Qualification

Quality Systems experienceSoftware as a Medical DeviceCAPA regulationsEQMSALM systemsISO 13485Project managementClear communicatorAnalyticalAttention to detailAdaptable